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Study to Assess the Safety and Pharmacokinetics of TPOXX® When Administered Orally for 28 Days

Smallpox Clinical Trial

Official title:
A Phase 1, Open-Label (JYNNEOS®), Double-Blind (TPOXX® And Placebo), Multicenter, Randomized, Placebo-Controlled, Drug-Vaccine Interaction Study To Evaluate the Impact of TPOXX on JYNNEOS Immunogenicity

Clinical Trial Summary

This study is designed to evaluate the immunogenicity profile of JYNNEOS® when 2 doses are administered subcutaneously (SC) 4 weeks apart; and potential immunological interference while concomitantly administering TPOXX or placebo orally twice daily (BID) for 28 days.

Clinical Trial Description

This is a Phase 2, open-label (JYNNEOS), double-blind (TPOXX and placebo), multicenter, randomized, placebo-controlled, drug-vaccine interaction study to examine whether administering TPOXX with JYNNEOS concomitantly affects JYNNEOS immunogenicity in healthy adult subjects. A total of 100 subjects (approximately 50 subjects per treatment group), ages 18 to 42, inclusive, will be enrolled and randomly assigned to 1 of 2 treatment groups. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT04957485
Study type Interventional
Source SIGA Technologies
Contact
Status Completed
Phase Phase 2
Start date January 5, 2022
Completion date May 5, 2023
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